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Monkeys with Parkinson’s disease benefit from human stem cells – Medical Xpress

Monkeys show reduced Parkinsonian symptoms following a donor-matched iPS cell-based therapy. Credit: Misaki Ouchida, Center for iPS Cell Research and Application, Kyoto University

One of the last steps before treating patients with an experimental cell therapy for the brain is confirmation that the therapy works in monkeys. Today, scientists at the Center for iPS Cell Research and Application (CiRA), Kyoto University, Japan, report monkeys with Parkinson's disease symptoms show significant improvement over two years after being transplanted neurons prepared from human iPS cells. The study, which can be read in Nature, is an expected final step before the first iPS cell-based therapy for neurodegenerative diseases.

Parkinson's disease degenerates a specific type of cells in the brain known as dopaminergic (DA) neurons. It has been reported that when symptoms are first detected, a patient will have already lost more than half of his or her DA neurons. Several studies have shown the transplantation of DA neurons made from fetal cells can mitigate the disease. The use of fetal tissues is controversial, however. On the other hand, iPS cells can be made from blood or skin, which is why Professor Takahashi, who is also a neurosurgeon specializing in Parkinson's disease, plans to use DA neurons made from iPS cells to treat patients.

"Our research has shown that DA neurons made from iPS cells are just as good as DA neurons made from fetal midbrain. Because iPS cells are easy to obtain, we can standardize them to only use the best iPS cells for therapy, " he said.

To test the safety and effectiveness of DA neurons made from human iPS cells, Tetsuhiro Kikuchi, a neurosurgeon working in the Takahashi lab, transplanted the cells into the brains of monkeys.

"We made DA neurons from different iPS cells lines. Some were made with iPS cells from healthy donors. Others were made from Parkinson's disease patients," said Kikuchi, who added that the differentiation method used to convert iPS cells into neurons is suitable for clinical trials.

It is generally assumed that the outcome of a cell therapy will depend on the number of transplanted cells that survive, but Kikuchi found this was not the case. More important than the number of cells was the quality of the cells.

"Each animal received cells prepared from a different iPS cell donor. We found the quality of donor cells had a large effect on the DA neuron survival," Kikuchi said.

To understand why, he looked for genes that showed different expression levels, finding 11 genes that could mark the quality of the progenitors. One of those genes was Dlk1.

"Dlk1 is one of the predictive markers of cell quality for DA neurons made from embryonic stem cells and transplanted into rat. We found Dlk1 in DA neurons transplanted into monkey. We are investigating Dlk1 to evaluate the quality of the cells for clinical applications."

Another feature of the study that is expected to extend to clinical study is the method used to evaluate cell survival in the host brains. The study demonstrated that magnetic resonance imaging (MRI) and position electron tomography (PET) are options for evaluating the patient post surgery.

"MRI and PET are non-invasive imaging modalities. Following cell transplantation, we must regularly observe the patient. A non-invasive method is preferred," said Takahashi.

The group is hopeful that it can begin recruiting patients for this iPS cell-based therapy before the end of next year. "This study is our answer to bring iPS cells to clinical settings," said Takahashi.

Explore further: Conversion of brain cells offers hope for Parkinson's patients

More information: Tetsuhiro Kikuchi et al. Human iPS cell-derived dopaminergic neurons function in a primate Parkinson's disease model, Nature (2017). DOI: 10.1038/nature23664

Journal reference: Nature

Provided by: Kyoto University

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Monkeys with Parkinson's disease benefit from human stem cells - Medical Xpress

Puppies receive stem cell treatment developed to help children with spina bifida – Sacramento Bee

A procedure combining surgery with stem cell treatment has aided two bulldog puppies with spina bifida and a team of UC Davis researchers hopes to test the therapy in human clinical trials.

The puppies were treated with a therapy developed at UC Davis to help preserve lower-limb function in children with spina bifida, according to a university news release.

Spina bifida occurs when spinal tissue improperly fuses in utero causing cognitive, mobility, urinary and bowel disabilities. Approximately 1,500 to 2,000 children in the United States are born with the condition each year.

Because dogs with the birth defect have little control of their hindquarters, they typically are euthanized as puppies.

After their post-surgery checkup at 4 months old, the sibling pups, Darla and Spanky, showed off their ability to walk, run and play.

The initial results of the surgery are promising, as far as hind limb control, veterinary neurosurgeon Beverly Sturges said in a written statement. Both dogs seemed to have improved range of motion and control of their limbs.

The dogs have since been adopted and continue to do well at home in New Mexico.

The dogs procedure involved surgical techniques developed by fetal surgeon Diana Farmer of UC Davis Health together with a cellular treatment developed by stem cell scientists Aijun Wang and Dori Borjesson, director of the universitys Veterinary Institute for Regenerative Cures.

Farmer pioneered the use of surgery prior to birth to improve brain development in children with spina bifida. She later showed that prenatal surgery combined with cells derived from the human placenta held in place with a cellular scaffold helped research lambs born with the disorder walk without noticeable disability, the news release said.

Sturges wanted to find out whether the surgery-plus-stem-cell approach could give dogs more normal lives, as well as better chances of survival and adoption.

Darla and Spanky were transported from Southern California Bulldog Rescue to the UC Davis Veterinary hospital when they were 10 weeks old. They were the first dogs to receive the treatment, this time using canine instead of human placenta-derived cells.

The dogs treatment also occurred after birth, because the prenatal diagnosis of spina bifida is not performed on dogs, Sturges said. The disorder becomes apparent between 1 and 2 weeks of ages, when puppies show hind-end weakness, poor muscle tone and abnormal use of their tails.

The research team wants dog breeders to send more puppies with spina bifida to UC Davis for treatment and refinements that will help researchers correct another hallmark of spina bifida, incontinence. Although Darla and Spanky are mobile and doing well, they still require diapers, the news release said.

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Puppies receive stem cell treatment developed to help children with spina bifida - Sacramento Bee

Veterinary Growth Partners Selects MediVet Biologics as Preferred Vendor for Veterinary Biologics – Benzinga

Stem Cell and other innovative biologic pet treatments now available medically to broad base of progressive veterinarians.

(PRWEB) August 24, 2017

Veterinary Growth Partners (VGP), a veterinary membership group with over 4,000 independent veterinary hospital members, helps practices accelerate their goals, growth and business success. VGP offers its members numerous benefits including preferred pricing, dedicated practice coaches, robust education for various job roles in the hospital, marketing tools, and some of the most impressive practice management tools in the industry. VGP has selected MediVet Biologics as a preferred vendor to provide its member hospitals access to innovative biologic treatments including advanced Stem Cell and Platelet Rich Plasma therapies for degenerative diseases in animals.

To date, over 12,000 animals have been treated with MediVet Biologics ActiStem stem cell treatment. ActiStem is the only US based animal stem cell treatment to be tested in a university randomized, double blind, placebo controlled trial.

In addition to regenerative medicine, Veterinary Growth Partners clinics will have access to K9-ACV, an immunotherapy vaccine designed to be an affordable option for canine cancer. The two organizations will provide education to the network of progressive veterinarians via innovative labs and learning experiences.

This signifies a continued shifting dynamic in pet healthcare with a focus on personalized and innovative medical treatment options being sought out for pets. Robert Sigman, CEO of VGP said, "Veterinary Growth Partners is excited to partner with MediVet Biologics. We strive to bring the best products and services in our industry to members at significant savings. MediVet's products are best in class. We look forward to working with them for many years to come."

"Pets are family members and their human families demand access to the same innovations and quality of care available in human medicine. We are here in the marketplace to provide our veterinary customers those options. Our partnership with VGP will continue to assist us in driving our mission to assist millions of animals across the globe", said Jeff Baker President of MediVet Biologics.

About MediVet BiologicsMediVet Biologics is a global leader in innovative medical solutions for the animal health market. The company has a portfolio of products and services to include regenerative medicine and immunotherapy for canine cancer. For more information please visit: http://www.medivetbiologics.com

About Veterinary Growth PartnersVeterinary Growth Partners is a membership organization for innovative veterinary practices. We bring you tools, templates, and cost-saving programs to grow your profit. To learn more about VGP, please visit: http://www.vgpvet.com

For the original version on PRWeb visit: http://www.prweb.com/releases/2017/08/prweb14629431.htm

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Veterinary Growth Partners Selects MediVet Biologics as Preferred Vendor for Veterinary Biologics - Benzinga

Terre Haute animal hospital in stem cell study for dogs – WISH-TV

Deana ReecePublished: August 23, 2017, 7:22 pmUpdated: August 23, 2017, 9:34 pm

TERRE HAUTE, Ind. (WTWO) Maggie Mae and her owner, Robert Howrey, came from Paris, Illinois, for a check-up at the Wabash Valley Animal Hospital in Terre Haute.

She doesnt act like it, but Maggie Mae is a senior citizen and she has problems with her joints.

Arthritis is a common condition in older dogs and we like to help them out, said Dr. Andrew Pickering, a local veterinarian.

A California company called Animal Cell Therapies has enlisted U.S. veterinarians to participate in a study of using stem cells for dogs with arthritis. Some of the canines in the study receive an injection of stem cells, others get just a saline solution.

Pickering doesnt know which injections Maggie Mae is getting, but she no longer limps. Hes encouraged by the results.

Were hoping this particular type of treatment will cure the condition for a long period of time so we dont have to keep giving the dog medication all the time, Pickering said.

Howrey said its almost like having a new dog.

Its been about six weeks, so now shes back doing normal activities, she runs, she chases squirrels.

The research will continue for several more months. The local clinic is looking for owners who would like to involve their pets. Study participation is free for dogs that qualify. Plus, even the animals that receive the saline injections can get the stem cell treatment once the study is complete.

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Cellectar Biosciences Inc (NASDAQ:CLRB) Pops Higher on Strong Research Data – The Oracle Dispatch

Cellectar Biosciences Inc (NASDAQ:CLRB)is a pharmaceutical stock thats popping up on everyones radar. This week has been an criticalweek for CLRB, as it blasted higher out of a key low consolidation on a strong jump in volume. The catalyst appears to be the CLRBs announcement this week that its Phospholipid Drug Conjugate research program has generated numerous PDC molecules that show significantly improved pharmacologic activity versus the payload molecule alone.

According to the release, utilizing a selection of novel linkers to attach proprietary cytotoxic molecules to the companys PDC platform, Cellectar has formulated new compounds specifically designed for improved tumor targeting and fewer off-target adverse effects. The research has demonstrated that with a variety of payloads, the phospholipid ether molecules provide, on average, a greater than 20-fold increase in delivery of the PDC to cancerous cells.

Cellectar Biosciences Inc (NASDAQ:CLRB) bills itself as a company developing agents to detect, treat and monitor a broad spectrum of cancers.

Utilizing a novel phospholipid ether (PLE) platform technology as a targeted delivery and retention vehicle, CLRBs compounds are designed to be selectively taken up and retained in both cancer cells and cancer stem cells. With the ability to attach both imaging and therapeutic agents to its proprietary delivery platform, Cellectar has developed a portfolio of product candidates engineered to capitalize on the unique characteristics of cancer cells to find, treat and follow malignancies in a highly selective way. I-124-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted PET imaging agent.

A Phase II trial evaluating I-124-CLR1404 in glioblastoma is expected to be completed in 2014. Additionally multiple, investigator sponsored Phase I/II clinical trials are ongoing across 11 solid tumor indications. I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. Data from a Phase Ib dose-escalation trial of I-131-CLR1404 in patients with advanced solid tumors is anticipated in the first quarter of 2014. CLR1502 is a preclinical, cancer-targeted, non-radioactive optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging.

CLRB was formerly known as Novelos Therapeutics, Inc. and changed its name to Cellectar Biosciences, Inc. in February 2014. Cellectar Biosciences, Inc. was founded in 2002 and is headquartered in Madison, Wisconsin.

Find outwhen $CLRB reaches critical levels. Subscribe to OracleDispatch.com Right Now by entering your Email in the box below.

As noted above, CLRB just popped off a key technical low on the companys announcement that its Phospholipid Drug Conjugate research program has generated numerous PDC molecules that apparently show significant improved pharmacologic activity versus the payload molecule alone. That could be huge news for the company.

The rapid advancement and positive data from these research programs, coupled with our ongoing collaborations, further validate the unique capabilities and broad utility of our PDC platform, said Jim Caruso, president and CEO of Cellectar Biosciences. We continue to drive our key internal programs in a strategic and cost-efficient manner including the advancement of candidate molecules from these new compound series. The company anticipates sharing additional technical details of this work either in peer reviewed journal articles or at a future oncology conference.

Recent action has seen 15% piled on for shareholders of the company during the trailing week, a bounce that has taken root amid largely bearish action over the larger time frame. Market participants may want to pay attention to this stock. CLRB is a stock whose past is littered with sudden rips. Whats more, the listing has seen interest climb, with an increase in recent trading volume of just shy of 150% over what the stock has registered over the longer term.

Earning a current market cap value of $24.92M, CLRBhas a significant war chest ($8.4M) of cash on the books, which is balanced by virtually no total current liabilities. The company is pre-revenue at this point. This is an exciting story, and we look forward to a follow-up chapter as events transpire.For continuing coverage on shares of $CLRB stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next breakoutpick!

Disclosure: We hold no position in $CLRB, either long or short, and we have not been compensated for this article.

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Cellectar Biosciences Inc (NASDAQ:CLRB) Pops Higher on Strong Research Data - The Oracle Dispatch

Stem cells could benefit cockapoo’s knee issue – Albuquerque Journal

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Dr. Nichol: If your cockapoo has somewhat bowed rear legs, one or both of her knee caps (patellas) may slip out of its groove at the lower end of her thigh bone. Some patellas dislocate (luxate) just occasionally. A dog may skip for a few steps and then use the leg normally again after the patella slips back into the groove.

The knees of a dog with luxating patellas are vulnerable to injury. Your girls missed jump may have strained the supportive tendons that guide her patella. Rest and anti-inflammatory medication can help in the short term but the anatomy would still be structurally unsound. The only permanent solution will be surgical remodeling of the attachment of her patella and the groove in her lower femur.

Called a tibial crest rotation this surgery is a long-established procedure that many veterinarians are skilled at performing. But even with the geometric forces corrected, some chronic damage to a dogs tendons and cartilage will remain. Thats what makes stem cell therapy valuable.

While your girl is under anesthesia for knee surgery her doctor can make a small abdominal incision and remove a bit of fat. Your dogs very own stem cells (no risk of rejection) will be processed and shipped back overnight for injection into her knee. Over the following weeks the stem cells will stimulate regeneration of chronically inflamed tissues, resulting in a stronger and more comfortable joint.

Finally, stem cell therapy, also known as regenerative medicine, is not new. Veterinary orthopedists have used stem cells for 15 years to speed healing and reach better long-term outcomes.

Each week I make a short video or podcast to help bring out the best in pets. Sign up at no charge on my website, drjeffnichol.com. Every Tuesday it will arrive in your email. Ill also send you my free Pet Emergency and CPR guide.

Dr. Jeff Nichol treats behavior disorders at the Veterinary Emergency & Specialty Centers in Albuquerque and Santa Fe (505-792-5131). Questions on pet behavioral or physical concerns? For answers, Like my Facebook page at facebook.com/drjeffnichol or by mail to 4000 Montgomery NE, Albuquerque, NM 87109.

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Stem cells could benefit cockapoo's knee issue - Albuquerque Journal

IN-DEPTH: Fighting for your life – Leavenworth Times

Julie Gould was heartbroken to learn that there was no cure for diffuse scleroderma, the chronic disease that she was diagnosed with in 2016.

Julie Gould was heartbroken to learn that there was no cure for diffuse scleroderma, the chronic disease that she was diagnosed with in 2016.The life-threatening auto-immune disease affects connective tissue in the body by producing too much collagen and hardening cartilage, tendons and skin.

I was depressed when I received the initial diagnosis, she said. It's difficult to hear that you may be dead in five years time. According to the Scleroderma Foundation, A person newly diagnosed with scleroderma may feel alone and uncertain about where to turn for help. He or she may experience a number of other feelings and emotional reactions from time to time, including initial shock or disbelief, fear, anger, denial, self-blame, guilt, grief, sadness or depression. Family members may have similar feelings.

When Julie first consulted a doctor in 2015, she was concerned that she might have picked up an infectious disease, such as a mosquito-born illness, or as she described it, the worst flu ever, during a vacation to Mexico. But she was told that diabetic neuropathy was causing the pins and needles tingling in her hands and feet.

My hands and feet continued to swell and I thought I had heart failure, said Julie. I went to a cardiologist to see if that was the problem. Those tests and lab work came back normal too.When the pain and swelling became excruciating, she consulted with a rheumatologist. When diabetic neuropathy was ruled out, she was told it could be rheumatoid arthritis. Although the lab tests were within normal limits, her doctor thought the labs werent correlating yet because it was so early in diagnosis. She was given medication and told to come back in six weeks, but saw no alleviation of the pain.

When her rheumatologist told her she might have scleroderma and ordered lab work, those tests too were normal.My physical therapist thought I should go to the Mayo Clinic, said Julie. I got online and requested an appointment. Three months later at the clinic in Rochester, Minnesota, she was diagnosed with diffuse scleroderma but it was a rare type that doesnt test positive in the usual lab test. Her total diagnosis wait had been a year and eight months, and she was more than ready to begin treatment. She was given multiple medications for pain and symptom control.After diagnosis, I got online and started searching for information about scleroderma, said Julie. It was dismal. I had to step away from the computer.Current treatments for the disease are varied, but basically treat the organs being affected. When lung tissue is hardened, patients are tube-fed and given oxygen. Sometimes lung transplants are required. Some patients need gastrointestinal surgery and some have operations to decrease ulcers on their fingers, while some must have their fingers and toes amputated.

Medication for high blood pressure and chemotherapy to suppress the disease are common with the disease and stiff joints and skin can result in patients not being able to stand upright and wheelchair-bound. Physical and occupational therapy is required to save body functions.Julies mother and sister, who is a nurse, also began scouring the internet for treatments. When they read about stem cell transplant they both felt this was the answer to Julies prayers.

Overcome with depression and pain, Julie began taking an antidepressant. With the help of the drug and limitless help and support from her family, the research on transplant gave her much needed hope. When I found out about the transplant, I was scared, said Julie. I feared for my life being taken by this disease.

This disease literally affects every organ system in the body. Transplant offered a chance to stop the disease in its tracks and stop further progression and damage to my body. I had been recently diagnosed, so the doctor said I could wait until I was worse, then have the transplant at a later date. I did not wait. I already had heart, lung, GI, and musculoskeletal systems involved. This approach was proactive, not reactive. It offered me hope.To qualify for stem cell treatment a patient must be sick enough toneed it, but not so sick that they would not benefit from the procedure.

We were able to find many groups to help us learn about scleroderma, she said. Inspire and Facebook were invaluable. There were specific groups for people who had scleroderma. Groups for people who needed a stem cell transplant. Groups for people with scleroderma, who wanted, or who already had a transplant.I started to read all the testimonials. I looked at the NIH website. This was productive research. I was finding out information on how to save my life not on how I was going to die.

After Julie applied for evaluation by Dr. Richard Burt at Northwestern in Chicago, she had scores of tests, including a CT scan of her lungs, MRI of her chest, EKG, sonogram of her heart, heart cath, colonoscopy, EGD, lab work, stress tests, psychological exam, dental exam, and 24-hour urine collection.

After all the anxious waiting during almost two years of doctor visits and tests, Julie was informed that she had passed the evaluation and had been approved for stem cell transplant.I came home to mentally prepare myself, said Julie. I returned to Chicago for the mobilization phase. I received a dose of chemo overnight in the hospital to suppress my immune disease. A week later I then started to give myself injections to produce white blood cells using neupogen. This medication forces the bone marrow to put out extra white blood cells, from which stem cells originate.

After six days of injections, Julie returned to the hospital to have the stem cells removed from her blood for use at a later date. She had to stay in Chicago during this part of treatment in case she had complications from the procedure. The process was similar to dialysis, said Julie. I was at the hospital all day, 12 hours. My own stem cells had been harvested to heal me. After two weeks of rest at home in Leavenworth, Julie returned to Chicago for the transplant. And after five days of more chemo, her stem cells were returned to her body. Now we only had to wait for the transplant to work, said Julie. I stayed in the hospital until the cells engrafted and my immune system started working again. Eight days.I had been in the hospital for 16 days. The transplant is a reboot to your diseased immune system like a reboot to your computer.Julie returned to Leavenworth to rest and recover. My entire family have been tremendously supportive, she said. They offered and provided all of the help that I needed to achieve this treatment.

She is also grateful to the community of Leavenworth for reaching out to help her. They donated money for my out-of-pocket expenses, said Julie. They provided food upon my return from Chicago. I didn't have to cook, nor did my husband for six weeks. Family cleaned my home and watched my children. I was grateful.

Social media also provided support during Julies treatment. She discovered a network of people on Facebook who had already had a transplant, or were waiting to have one. Stem cells are used to treat many auto-immune disorders like multiple sclerosis, lupus, Crohns disease, and many others, said Julie. I could pose any question to this forum and receive an answer. I started my own Facebook page to document my medical treatment so that I too could share my information. It has been wonderful to help others who are experiencing what I have been through.

Julie has just returned from her one-year checkup in Chicago and learned that the progression of the disease has stopped. Stem cell transplant has saved my life, said Julie. I am living, not merely existing.Not only has the disease been stopped in its tracks, Julie has seen physical improvements such as full motion in her shoulder, which was frozen from hardened tissue for much of the last few years. Her contracted hands are also more mobile and she has gained 40 degrees movement in some of her fingers.

I have Raynaud's syndrome, said Julie. It has improved. It was a constant struggle to keep my hands and feet warm. The pain in my hands is mostly gone. The all-over joint pain is gone. The fatigue and malaise are gone. I feel good. I feel happy.As she has regained her back strength and dexterity she is now able to enjoy the routine of normal days, like rising from a chair without pain, sleeping and eating well and even doing simple tasks such as opening a jar, which was difficult after her diagnosis.Everyday tasks were difficult, said Julie. Deodorant, flossing, brushing teeth or hair, dressing. All of the daily activities have gotten easier everyday. The pain is mostly gone.My body feels healthy.

Julie has gained much more than flexibility and relief from constant pain during her long medical challenge, and she emphasizes, I learned to not sweat the small stuff. I learned to live every day. I learned to love every day.

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Health Advice | 8/16/17 – KTNV Las Vegas


KTNV Las Vegas
Health Advice | 8/16/17
KTNV Las Vegas
Many kids are diagnosed with ADHD--some incorrectly. What may appear to be the behavior of a child with ADHD might actually be symptoms of epilepsy. AdvancedNeuro.net. This segment is sponsored by Advanced Neurodiagnostics & Sleep Center.

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Health Advice | 8/16/17 - KTNV Las Vegas

Aratana Therapeutics Reports Second Quarter 2017 Financial Results – Markets Insider

LEAWOOD, Kan., Aug. 3, 2017 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative therapeutics for dogs and cats, announced its second quarter 2017 financial results. For the quarter ended June 30, 2017, Aratana reported total net revenues of $5.2 million and a net loss of $10.4 million or $0.26 diluted loss per share.

"We are pleased with the continued customer adoption of Galliprant and Nocita," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "In addition, we continue to advance our next wave of therapeutic candidates as evidenced by several recent regulatory submissions and a positive pivotal efficacy study in cats."

Recent Updates

Financial Results

The second quarter net loss was $10.4 million or $0.26 diluted loss per share compared to net income of $21.2 million or $0.61 diluted net income per share for the corresponding quarter ended June 30, 2016. Aratana recorded $5.2 million in net revenues for the quarter ended June 30, 2017, which primarily includes approximately $3.7 million related to GALLIPRANT product sales as finished goods under its supply arrangement with Elanco, $804 thousand in GALLIPRANT licensing and collaboration revenue, and $637 thousand in NOCITA net product sales. The second quarter of 2016 included $38.1 million in net revenues of which, $38.0 million was the result of the GALLIPRANT Collaboration Agreement.

The cost of product sales totaled $3.7 million in the second quarter of 2017 in comparison to $1.7 million for the corresponding period in 2016. The increase in the second quarter of 2017 was primarily due to GALLIPRANT supply sold to Elanco for commercial distribution, as well as cost of product sales of NOCITA. In July, pursuant to our Collaboration Agreement, Elanco provided notice of its intent to assume responsibility for manufacturing and its intent to assume the registrations of the therapeutic. Aratana believes the transfers of manufacturing and the registration in the U.S. to Elanco will be completed by December 31, 2017.

Research and development expenses totaled $3.7 million in the second quarter ended June 30, 2017 in comparison to $5.3 million for the quarter ended June 30, 2016. The decrease was primarily due to lower milestone payments as compared to 2016.

Selling, general and administrative expenses totaled $6.9 million for the second quarter ended June 30, 2017 compared to $6.1 million for the corresponding period in 2016. The increase is primarily related to the expanded commercial organization. Aratana expects selling, general and administrative expenses to remain relatively consistent through the remainder of 2017 with the corporate infrastructure substantially in place to support the commercialization of NOCITA and GALLIPRANT, as well as the anticipated commercialization of ENTYCE.

As of June 30, 2017, Aratana had approximately $80.7 million in cash, cash equivalents, restricted cash and short-term investments, which includes approximately $26.0 million in net proceeds from the sale of shares of the Company's common stock in the second quarter of 2017.

For the full year 2017, the Company continues to estimate operating expenses of approximately $45 million, resulting in a year-end cash balance of approximately $65 million.

The Company believes that its existing cash, cash equivalents, short-term investments and restricted cash of $80.7 million as of June 30, 2017 will allow Aratana to fund the current operating plan and debt obligations through at least 2018. The Company's current operating plan contemplates the launch of ENTYCE by the fall of 2017, as well as continued growth of our commercially available therapeutics.

Webcast & Conference Call Details

The Company will host a live conference call on Friday, August 4, 2017 at 8:30 a.m. ET to discuss financial results from the second quarter ended June 30, 2017.

Interested participants and investors may access the audio webcast or use the conference call dial-in:

1 (866) 364-3820 (U.S.) 1 (855) 669-9657 (Canada) 1 (412) 902-4210 (International)

A replay of the second quarter results teleconference will be available the same day of the event by approximately 11 a.m. ET and an audio webcast will be accessible for 90 days in the Aratana Investor Room. For a replay of the call, use the below dial-in and conference ID 10110825:

1 (877) 344-7529 (U.S.) 1 (855) 669-9658 (Canada) 1 (412) 317-0088 (International)

IMPORTANT SAFETY INFORMATION

GALLIPRANT (grapiprant tablets) is not for use in humans. For use in dogs only. Keep this and all medications out of reach of children and pets. Store out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Do not use in dogs that have a hypersensitivity to grapiprant. If Galliprant is used long term, appropriate monitoring is recommended. Concomitant use of Galliprant with other anti-inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. Concurrent use with other anti-inflammatory drugs or protein-bound drugs has not been studied. The safe use of Galliprant has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, pregnant or lactating dogs, or dogs with cardiac disease. The most common adverse reactions were vomiting, diarrhea, decreased appetite, and lethargy. Please see full product label for fullprescribing information.

ENTYCE (capromorelin oral solution) is for use in dogs only. Do not use in breeding, pregnant or lactating dogs. Use with caution in dogs with hepatic dysfunction or renal insufficiency. Adverse reactions in dogs may include diarrhea, vomiting, polydipsia, and hypersalivation. Should not be used in dogs that have a hypersensitivity to capromorelin. Please see the fullPrescribing Informationfor more detail.

NOCITA (bupivacaine liposome injectable suspension) is for use in dogs only. Do not use in dogs younger than 5 months of age, dogs used for breeding, or in pregnant or lactating dogs. Do not administer by intravenous or intra-arterial injection. Adverse reactions in dogs may include discharge from incision, incisional inflammation and vomiting. Avoid concurrent use with bupivacaine HCI, lidocaine or other amide local anesthetics. Please see the fullPrescribing Informationfor more detail.

About Aratana Therapeutics

Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative therapeutics for dogs and cats. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to dogs and cats in a capital and time efficient manner. The Company's pipeline includes therapeutic candidates for the potential treatment of pain, inappetence, viral diseases, allergy, cancer and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit http://www.aratana.com.

Forward-Looking Statements Disclaimer

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements with respect to anticipated financial performance, our ability to bring innovative therapeutics to the market; steps necessary for and timing of regulatory submissions and approvals of therapeutic candidates; study, development and commercialization of therapeutics or therapeutic candidates; timing of anticipated study results; increased market recognition of and demand for our therapeutics; Elanco's intent to assume responsibility for manufacturing and regulatory approval for GALLIPRANT under the Collaboration Agreement; our belief that if our prior approval submission is approved, the Company would be able to make ENTYCE commercially available by the fall of 2017, depending on the timing of CVM's approval, if any, of the PAS; expectations regarding trends in cost of product sales; anticipated 2017 operating expenses and year-end cash balance; and statements regarding the Company's efforts, plans and opportunities, including, without limitation, advancing our therapeutic candidates and offering innovative therapeutics that help manage pet's medical needs safely and effectively and that result in longer and improved quality of life for pets.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risk that the securities offering will not close in the timeframe we expect, or at all; the amount of net proceeds we receive from such offering and how we use them may differ from our current expectations; our history of operating losses and our expectation that we will continue to incur losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; risks relating to the impairment of intangible assets, including BLONTRESS, TACTRESS, AT-007 and AT-011; risks pertaining to stockholder class action lawsuits; unstable market and economic conditions; restrictions on our financial flexibility due to the terms of our credit facility; our substantial dependence upon the commercial success of our therapeutics; development of our biologic therapeutic candidates is dependent upon relatively novel technologies and uncertain regulatory pathways, and biologics may not be commercially viable; denial or delay of regulatory approval for our existing or future therapeutic candidates; failure of our therapeutic candidates that receive regulatory approval to achieve market acceptance or achieve commercial success; product liability lawsuits that could cause us to incur substantial liabilities and limit commercialization of current and future therapeutics; failure to realize anticipated benefits of our acquisitions and difficulties associated with integrating the acquired businesses; development of pet therapeutics is a lengthy and expensive process with an uncertain outcome; competition in the pet therapeutics market, including from generic alternatives to our therapeutic candidates, and failure to compete effectively; failure to identify, license or acquire, develop and commercialize additional therapeutic candidates; failure to attract and retain senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers and partners; regulatory restrictions on the marketing of our approved therapeutics and therapeutic candidates; our small commercial sales organization, and any failure to create a sales force or collaborate with third-parties to commercialize our approved therapeutics and therapeutic candidates; difficulties in managing the growth of our company; significant costs of being a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013, and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our veterinarian customers; limitations on our ability to use our net operating loss carryforwards; impacts of generic products; safety or efficacy concerns with respect to our therapeutic candidates; effects of system failures or security breaches; delay or termination of the development of grapiprant therapeutic candidates and commercialization of grapiprant products that may arise from termination of or failure to perform under the collaboration agreement and/or the co-promotion agreement with Elanco; failure to obtain ownership of issued patents covering our therapeutic candidates or failure to prosecute or enforce licensed patents; failure to comply with our obligations under our license agreements; effects of patent or other intellectual property lawsuits; failure to protect our intellectual property; changing patent laws and regulations; non-compliance with any legal or regulatory requirements; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process and the costs associated with government regulation of our therapeutic candidates; failure to obtain regulatory approvals in foreign jurisdictions; effects of legislative or regulatory reform with respect to pet therapeutics; the volatility of the price of our common stock; our status as an emerging growth company, which could make our common stock less attractive to investors; dilution of our common stock as a result of future financings; the influence of certain significant stockholders over our business; and provisions in our charter documents and under Delaware law could delay or prevent a change in control. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 14, 2017, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts For investor inquires: Craig Toomanrel="nofollow">ctooman@aratana.com(913) 353-1026

For media inquiries: Rachel Reiffrel="nofollow">rreiff@aratana.com(913) 353-1050

ARATANA THERAPEUTICS, INC.

Consolidated Statements of Operations (Unaudited)

(Amounts in thousands, except share and per share data)

Three Months Ended

Six Months Ended

June 30,

June 30,

2017

2016

2017

2016

Revenues

Licensing and collaboration revenue

$

804

$

38,000

$

1,707

$

38,151

Product sales

4,354

47

7,246

68

Total revenues

5,158

38,047

8,953

38,219

Costs and expenses

Cost of product sales

3,691

1,741

6,785

1,760

Royalty expense

353

20

676

38

Research and development

3,700

5,303

8,354

16,052

Selling, general and administrative

6,918

6,148

14,413

12,699

Amortization of intangible assets

86

95

150

190

Impairment of intangible assets

2,780

2,780

Total costs and expenses

14,748

16,087

30,378

33,519

Originally posted here:
Aratana Therapeutics Reports Second Quarter 2017 Financial Results - Markets Insider

Aratana Therapeutics Reports Second Quarter 2017 Financial Results – PR Newswire (press release)

"We are pleased with the continued customer adoption of Galliprant and Nocita," stated Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. "In addition, we continue to advance our next wave of therapeutic candidates as evidenced by several recent regulatory submissions and a positive pivotal efficacy study in cats."

Recent Updates

Financial Results

The second quarter net loss was $10.4 million or $0.26 diluted loss per share compared to net income of $21.2 million or $0.61 diluted net income per share for the corresponding quarter ended June 30, 2016. Aratana recorded $5.2 million in net revenues for the quarter ended June 30, 2017, which primarily includes approximately $3.7 million related to GALLIPRANT product sales as finished goods under its supply arrangement with Elanco, $804 thousand in GALLIPRANT licensing and collaboration revenue, and $637 thousand in NOCITA net product sales. The second quarter of 2016 included $38.1 million in net revenues of which, $38.0 million was the result of the GALLIPRANT Collaboration Agreement.

The cost of product sales totaled $3.7 million in the second quarter of 2017 in comparison to $1.7 million for the corresponding period in 2016. The increase in the second quarter of 2017 was primarily due to GALLIPRANT supply sold to Elanco for commercial distribution, as well as cost of product sales of NOCITA. In July, pursuant to our Collaboration Agreement, Elanco provided notice of its intent to assume responsibility for manufacturing and its intent to assume the registrations of the therapeutic. Aratana believes the transfers of manufacturing and the registration in the U.S. to Elanco will be completed by December 31, 2017.

Research and development expenses totaled $3.7 million in the second quarter ended June 30, 2017 in comparison to $5.3 million for the quarter ended June 30, 2016. The decrease was primarily due to lower milestone payments as compared to 2016.

Selling, general and administrative expenses totaled $6.9 million for the second quarter ended June 30, 2017 compared to $6.1 million for the corresponding period in 2016. The increase is primarily related to the expanded commercial organization. Aratana expects selling, general and administrative expenses to remain relatively consistent through the remainder of 2017 with the corporate infrastructure substantially in place to support the commercialization of NOCITA and GALLIPRANT, as well as the anticipated commercialization of ENTYCE.

As of June 30, 2017, Aratana had approximately $80.7 million in cash, cash equivalents, restricted cash and short-term investments, which includes approximately $26.0 million in net proceeds from the sale of shares of the Company's common stock in the second quarter of 2017.

For the full year 2017, the Company continues to estimate operating expenses of approximately $45 million, resulting in a year-end cash balance of approximately $65 million.

The Company believes that its existing cash, cash equivalents, short-term investments and restricted cash of $80.7 million as of June 30, 2017 will allow Aratana to fund the current operating plan and debt obligations through at least 2018. The Company's current operating plan contemplates the launch of ENTYCE by the fall of 2017, as well as continued growth of our commercially available therapeutics.

Webcast & Conference Call Details

The Company will host a live conference call on Friday, August 4, 2017 at 8:30 a.m. ET to discuss financial results from the second quarter ended June 30, 2017.

Interested participants and investors may access the audio webcast or use the conference call dial-in:

1 (866) 364-3820 (U.S.) 1 (855) 669-9657 (Canada) 1 (412) 902-4210 (International)

A replay of the second quarter results teleconference will be available the same day of the event by approximately 11 a.m. ET and an audio webcast will be accessible for 90 days in the Aratana Investor Room. For a replay of the call, use the below dial-in and conference ID 10110825:

1 (877) 344-7529 (U.S.) 1 (855) 669-9658 (Canada) 1 (412) 317-0088 (International)

IMPORTANT SAFETY INFORMATION

GALLIPRANT (grapiprant tablets) is not for use in humans. For use in dogs only. Keep this and all medications out of reach of children and pets. Store out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Do not use in dogs that have a hypersensitivity to grapiprant. If Galliprant is used long term, appropriate monitoring is recommended. Concomitant use of Galliprant with other anti-inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. Concurrent use with other anti-inflammatory drugs or protein-bound drugs has not been studied. The safe use of Galliprant has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, pregnant or lactating dogs, or dogs with cardiac disease. The most common adverse reactions were vomiting, diarrhea, decreased appetite, and lethargy. Please see full product label for fullprescribing information.

ENTYCE (capromorelin oral solution) is for use in dogs only. Do not use in breeding, pregnant or lactating dogs. Use with caution in dogs with hepatic dysfunction or renal insufficiency. Adverse reactions in dogs may include diarrhea, vomiting, polydipsia, and hypersalivation. Should not be used in dogs that have a hypersensitivity to capromorelin. Please see the fullPrescribing Informationfor more detail.

NOCITA (bupivacaine liposome injectable suspension) is for use in dogs only. Do not use in dogs younger than 5 months of age, dogs used for breeding, or in pregnant or lactating dogs. Do not administer by intravenous or intra-arterial injection. Adverse reactions in dogs may include discharge from incision, incisional inflammation and vomiting. Avoid concurrent use with bupivacaine HCI, lidocaine or other amide local anesthetics. Please see the fullPrescribing Informationfor more detail.

About Aratana Therapeutics

Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative therapeutics for dogs and cats. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to dogs and cats in a capital and time efficient manner. The Company's pipeline includes therapeutic candidates for the potential treatment of pain, inappetence, viral diseases, allergy, cancer and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit http://www.aratana.com.

Forward-Looking Statements Disclaimer

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements with respect to anticipated financial performance, our ability to bring innovative therapeutics to the market; steps necessary for and timing of regulatory submissions and approvals of therapeutic candidates; study, development and commercialization of therapeutics or therapeutic candidates; timing of anticipated study results; increased market recognition of and demand for our therapeutics; Elanco's intent to assume responsibility for manufacturing and regulatory approval for GALLIPRANT under the Collaboration Agreement; our belief that if our prior approval submission is approved, the Company would be able to make ENTYCE commercially available by the fall of 2017, depending on the timing of CVM's approval, if any, of the PAS; expectations regarding trends in cost of product sales; anticipated 2017 operating expenses and year-end cash balance; and statements regarding the Company's efforts, plans and opportunities, including, without limitation, advancing our therapeutic candidates and offering innovative therapeutics that help manage pet's medical needs safely and effectively and that result in longer and improved quality of life for pets.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risk that the securities offering will not close in the timeframe we expect, or at all; the amount of net proceeds we receive from such offering and how we use them may differ from our current expectations; our history of operating losses and our expectation that we will continue to incur losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; risks relating to the impairment of intangible assets, including BLONTRESS, TACTRESS, AT-007 and AT-011; risks pertaining to stockholder class action lawsuits; unstable market and economic conditions; restrictions on our financial flexibility due to the terms of our credit facility; our substantial dependence upon the commercial success of our therapeutics; development of our biologic therapeutic candidates is dependent upon relatively novel technologies and uncertain regulatory pathways, and biologics may not be commercially viable; denial or delay of regulatory approval for our existing or future therapeutic candidates; failure of our therapeutic candidates that receive regulatory approval to achieve market acceptance or achieve commercial success; product liability lawsuits that could cause us to incur substantial liabilities and limit commercialization of current and future therapeutics; failure to realize anticipated benefits of our acquisitions and difficulties associated with integrating the acquired businesses; development of pet therapeutics is a lengthy and expensive process with an uncertain outcome; competition in the pet therapeutics market, including from generic alternatives to our therapeutic candidates, and failure to compete effectively; failure to identify, license or acquire, develop and commercialize additional therapeutic candidates; failure to attract and retain senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers and partners; regulatory restrictions on the marketing of our approved therapeutics and therapeutic candidates; our small commercial sales organization, and any failure to create a sales force or collaborate with third-parties to commercialize our approved therapeutics and therapeutic candidates; difficulties in managing the growth of our company; significant costs of being a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013, and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our veterinarian customers; limitations on our ability to use our net operating loss carryforwards; impacts of generic products; safety or efficacy concerns with respect to our therapeutic candidates; effects of system failures or security breaches; delay or termination of the development of grapiprant therapeutic candidates and commercialization of grapiprant products that may arise from termination of or failure to perform under the collaboration agreement and/or the co-promotion agreement with Elanco; failure to obtain ownership of issued patents covering our therapeutic candidates or failure to prosecute or enforce licensed patents; failure to comply with our obligations under our license agreements; effects of patent or other intellectual property lawsuits; failure to protect our intellectual property; changing patent laws and regulations; non-compliance with any legal or regulatory requirements; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process and the costs associated with government regulation of our therapeutic candidates; failure to obtain regulatory approvals in foreign jurisdictions; effects of legislative or regulatory reform with respect to pet therapeutics; the volatility of the price of our common stock; our status as an emerging growth company, which could make our common stock less attractive to investors; dilution of our common stock as a result of future financings; the influence of certain significant stockholders over our business; and provisions in our charter documents and under Delaware law could delay or prevent a change in control. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 14, 2017, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts For investor inquires: Craig Toomanctooman@aratana.com (913) 353-1026

For media inquiries: Rachel Reiffrreiff@aratana.com (913) 353-1050

ARATANA THERAPEUTICS, INC.

Consolidated Statements of Operations (Unaudited)

(Amounts in thousands, except share and per share data)

Three Months Ended

Six Months Ended

June 30,

June 30,

2017

2016

2017

2016

Revenues

Licensing and collaboration revenue

$

804

$

38,000

$

1,707

$

38,151

Product sales

4,354

47

7,246

68

Total revenues

5,158

38,047

8,953

38,219

Costs and expenses

Cost of product sales

3,691

1,741

6,785

1,760

Royalty expense

353

20

676

38

Research and development

3,700

5,303

8,354

16,052

Selling, general and administrative

6,918

6,148

14,413

12,699

Amortization of intangible assets

86

95

150

190

Impairment of intangible assets

2,780

2,780

Total costs and expenses

14,748

16,087

30,378

33,519

Income (loss) from operations

(9,590)

21,960

(21,425)

Read the original post:
Aratana Therapeutics Reports Second Quarter 2017 Financial Results - PR Newswire (press release)

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